A Care Model for Hip-fractured Elderly Persons With Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Hip Fracture
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Diabetes interdisciplinary program
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Age 60 years or older (this criterion is based on our previous NHRI-funded study: Intervention program for elderly patients with hip fracture, 2001-2003),
- Diagnosed with DM,
- Admitted to CGMH from its emergency room due to hip fracture, and
- Living in northern Taiwan (i.e.,greater Taipei area, Keelung, Taoyuan, or Shin-Ju Province).
Exclusion Criteria:
- Clinical diagnosis of Cancer
- Can't communicate with researchers
Sites / Locations
- Chang Gung Memorial Hospital, Taiwan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interdisciplinary group
Control group
Arm Description
Diabetes intervention and rehabilitation program. The rehabilitation program includes geriatric consultation, the rehabilitation program (interventions to improve ROM, muscle strength and endurance, proprioceptive enhancement, balance capacity, aerobic and anaerobic capacity, flexibility, and body composition), and discharge-planning services. The DM intervention includes: dietary and DM education, blood pressure control, dyslipidemia management, a glycemic treatment regimen, and exercises.
Routine care
Outcomes
Primary Outcome Measures
Quality of life
Secondary Outcome Measures
Activities of Daily life
Full Information
NCT ID
NCT01051830
First Posted
January 17, 2010
Last Updated
February 6, 2017
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Health Research Institutes, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT01051830
Brief Title
A Care Model for Hip-fractured Elderly Persons With Diabetes Mellitus
Official Title
A Care Model for Hip-fractured Elderly Persons With Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Health Research Institutes, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to 1) develop a well-conceived and feasible protocol for hospital discharge and subacute care for hip-fractured elderly persons with DM, and 2) compare the costs and effectiveness of this DM-specific model with those of an effective subacute care model previously developed by our research team.
Detailed Description
Clinical and scientific significance. Health outcomes, as well as physical and cognitive function, have been shown to be negatively impacted by comorbidity beyond the bare sum of effects due to the single diseases. One such comorbidity is diabetes mellitus (DM), a global health issue and the fifth major cause of death in Taiwan from 1987 to 2001. Starting in 2002, DM has become the fourth. Hip-fractured elderly persons with DM were shown in our previous studies to have significantly higher mortality and readmission rates and poorer recovery in walking ability and various physical health outcomes than those without DM during the first year after discharge. Clinical evidence has shown that elderly patients with hip fracture can benefit from postoperative rehabilitation, early discharge-planning programs, or transitional care programs. However, little is known about effective interventions specifically for hip fractured patients with DM.
Research Purposes. The purpose of this study is to 1) develop a well-conceived and feasible protocol for hospital discharge and subacute care for hip-fractured elderly persons with DM, and 2) compare the costs and effectiveness of this DM-specific model with those of an effective subacute care model previously developed by our research team.
Data and Methods. A clinical trial with 1-year follow-up will be used to compare the cost-effectiveness of the DM-specific model in 88 hip-fractured elderly patients with that of our subacute care model (n=88) and routine care (n=88). Patients will be recruited through the emergency room of Chang Gung Memorial Hospital (CGMH) at Lin Kuo. Subjects will be assessed before surgery, before discharge, at 1, 3, 6, and 12 months after discharge for biometric measures, DM-related outcomes, clinical outcomes, self-care ability, health-related quality of life, service utilization, and costs of care. To maximize outcomes sensitive to the intervention, biometric measures of activity will be included, i.e., daily energy consumption and arterial stiffness index. DM-related variables will include haemoglobin A1c (HbA1c), tendon reflexes, superficial and deep sensation, peripheral pulses, diabetic retinopathy, signs of "diabetic foot," use of medication, and clinical procedures. The study has already been approved by the Institutional Review Board of CGMH. Trajectories of the outcome variables and their predictors will be analyzed by the generalized estimating equations (GEE) approach. The cost of the three care models will also be compared. Findings of this study can contribute to current knowledge and practice for elderly patients with DM recovering from hip-fracture surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Hip Fracture
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interdisciplinary group
Arm Type
Experimental
Arm Description
Diabetes intervention and rehabilitation program. The rehabilitation program includes geriatric consultation, the rehabilitation program (interventions to improve ROM, muscle strength and endurance, proprioceptive enhancement, balance capacity, aerobic and anaerobic capacity, flexibility, and body composition), and discharge-planning services. The DM intervention includes: dietary and DM education, blood pressure control, dyslipidemia management, a glycemic treatment regimen, and exercises.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Routine care
Intervention Type
Other
Intervention Name(s)
Diabetes interdisciplinary program
Intervention Description
Diabetes consulting, rehabilitation program
Primary Outcome Measure Information:
Title
Quality of life
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Activities of Daily life
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 60 years or older (this criterion is based on our previous NHRI-funded study: Intervention program for elderly patients with hip fracture, 2001-2003),
Diagnosed with DM,
Admitted to CGMH from its emergency room due to hip fracture, and
Living in northern Taiwan (i.e.,greater Taipei area, Keelung, Taoyuan, or Shin-Ju Province).
Exclusion Criteria:
Clinical diagnosis of Cancer
Can't communicate with researchers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yea-Ing L Shyu, PhD
Organizational Affiliation
Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital, Taiwan
City
Taipei, Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34766330
Citation
Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.
Results Reference
derived
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A Care Model for Hip-fractured Elderly Persons With Diabetes Mellitus
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